Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JST · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
46 daysmedian FDA review time
99 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962423 | BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM | Becton Dickinson Microbiology Systems | 1996-08-02 | 39 | 0 |
| K854732 | API 50 CHB (CULTURE MEDIA) | Dms Products, Inc. | 1986-03-04 | 99 | 0 |
| K841661 | SYNTHETIC BROTH A.O.A.C. | Oxoid U.S.A., Inc. | 1984-05-11 | 18 | 0 |
| K832239 | RIM-HAEMOPHILUS 2 | Austin Biological Laboratories | 1983-08-12 | 46 | 0 |
| K832051 | RIM-HAEMOPHILUS 1 & 2 | Austin Biological Laboratories | 1983-08-12 | 49 | 0 |
| K831349 | STREPTOCOCUS ID PLATE | Granite Diagnostics, Inc. | 1983-05-16 | 21 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda